Reported Oct 27, 2021 · Terminated
smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- smiths medical portex Loss of Resistance Device, REF 100/398/000
- Lot codes and dates
- Lot Numbers
3980977398673439943023994303 and 4001003
- Lot Numbers
- Amount recalled
- 3420 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
The labeling was missing information on sterilization and prohibition of reuse.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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